Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000060347
Ethics application status
Approved
Date submitted
6/01/2017
Date registered
11/01/2017
Date last updated
23/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A study that test the effects of a mobile phone application that delivers a psychological health intervention to reduce social anxiety symptoms.
Scientific title
Randomised Controlled Trail testing the effectiveness of an Ecological Momentary Intervention (EMI) in adults with social anxiety symptoms
Secondary ID [1] 290858 0
None
Universal Trial Number (UTN)
U1111-1191-4149
Trial acronym
Ecological Momentary Intervention (EMI)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Anxiety 301542 0
Generalised Anxiety 301543 0
Depression 301544 0
Psychological Distress 301545 0
Condition category
Condition code
Mental Health 301262 301262 0 0
Anxiety
Mental Health 301263 301263 0 0
Depression
Mental Health 301264 301264 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consist of a mobilephone application consist of 4 brief modules that encapsulate steps for learning and conducting exposure therapy at moments when a person experiences symptoms. No formal name has been given to the mobile app, however “Exposure Practice” comes up as title of the application before presented the modules. In order to successfully complete all modules, a participant must complete the modules in chronological order. Participants are required to open mobilephone application to access and complete each module, including during times when anxiety symptoms may occur. We estimate each module will take 10-15 minutes to complete however it requires participants to repeatedly engage with the exercises daily. Furthermore, we estimate participants will engage with the mobile application 2 to 5 minutes daily, and at least 1 to 3 times per day to complete all modules over a 4 weeks period.
The first module consists of text and image material about exposure therapy. For example, a participant will learn about what exposure therapy is, why use exposure therapy, the evidence on exposure therapy, and how to use exposure therapy. The second module requires participants to identify personal factors relating to their social anxiety. For example, participants will learn to identify their challenging situations, physical symptoms, anxious behaviours, and unhelpful thoughts. The module consists of text and image material about how to identify these factors with the ability to record these factors into the mobilephone application. The third module requires participants to prepare and plan for exposure therapy. For example, participants will be able to learn about how to use self-talk strategies to cope with anxieties before exposure to situations, using rehearsal and roleplay techniques, breathing techniques to regulate emotions during exposure to situations, and to use the mobilephone application to plan for exposure practice. The fourth module requires the participant to practice exposure therapy in a variety of situations and settings. For example, participant will require to engage with challenging situation following each screen presented in the mobilephone application. The participant can select the challenging situation to do, followed by a brief assessment in the mobilephone application to examine anxiety level before the situation. After the participant engage with a situation, another brief mobilephone application will be given to the participant to record their anxiety levels after the situation, and what they have learnt during exposure. Once completed exposure to a situation, the participant is given the choice to continue with the same situation or try a different situation using the mobilephone application.
Data such as the number of times a participant access the mobilephone application and individual modules will be tracked using a secure remote server in Australia. No geo-location or other similar services will be used to monitor participant’s usage.
Intervention code [1] 296800 0
Treatment: Other
Intervention code [2] 296801 0
Behaviour
Intervention code [3] 296802 0
Treatment: Devices
Comparator / control treatment
Waitlist control group. Participants allocated to the control group will receive the same instructions for the mobilephone application 4 weeks after group one has received the mobile app.
Control group
Active

Outcomes
Primary outcome [1] 300674 0
Social anxiety symptoms using Social Phobia Screener (SOPHS) questionnaire
Timepoint [1] 300674 0
SOPHS will be assessed at baseline before participant are randomised and allocated to study group, SOPHS will be also assessed at 4 weeks after allocation to study group
Secondary outcome [1] 330577 0
Social anxiety using Mini-Social Phobia Inventory (Mini-SPIN) questionnaire
Timepoint [1] 330577 0
Mini-SPIN will be assessed at baseline before pariticipant are randomised and allocated to study group, Mini-SPIN will be also assessed at 4 weeks after allocation to study group
Secondary outcome [2] 330581 0
Anxiety sensitivity using the Anxiety Sensitivity Index (ASI) questionnaire
Timepoint [2] 330581 0
ASI will be assessed at baseline before participant are randomised and allocated to study group. ASI will be also assessed at 4 weeks after allocation to study group.
Secondary outcome [3] 330582 0
Psychological distress using the Distress Questionnaire-5 (DQ5) assessment
Timepoint [3] 330582 0
DQ5 will be assessed at baseline before participant are randomised and allocated to study group. DQ5 will be also assessed at 4 weeks after allocation to study group.
Secondary outcome [4] 330583 0
Generalised Anxiety and Depression will be assessed using the Patient Health Questionnaire-4 (PHQ-4) assessment
Timepoint [4] 330583 0
PHQ-4 will be assessed at baseline before participant are randomised and allocated to study group. PHQ-4 will be also assessed at 4 weeks after allocation to study group.
Secondary outcome [5] 330584 0
Help seeking behaviours will be assessed using the Actual Help-Seeking Questionnaire (AHSQ) and The General Help-Seeking Questionnaire (GHSQ).
Timepoint [5] 330584 0
AHSQ and GHSQ will be assessed at baseline before participant are randomised and allocated to study group. AHSQ and GHSQ will be also assessed at 4 weeks after allocation to study group.
Secondary outcome [6] 330585 0
7 questions will assess the user satisfaction of the mobilephone application. Participants can make a rating from 1-10 where 1 means completely disagree, and 10 meaning completed agree.
Timepoint [6] 330585 0
Satisfaction questions will be assessed at 4 weeks after being allocated to study group.

Eligibility
Key inclusion criteria
Age over 18, sufficient English language ability to complete the baseline and post-test assessments, provision of a valid email address and an Apple iPhone, iPad, or iPod touch device with internet access, consent to participate in the trial, all participants must have social anxiety symptoms, and scoring below 16 for social anxiety symptoms (SOPHS).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Meeting criteria for high levels of social anxiety (SOPHS>16), currently perscribed medication for anxiety and depression problems, and currently undertaking psychotherapy for anxiety and depression problems, and self-reported bipolar disorder and schizophrenia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed will be through randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software. Stratification will be employed in the study. Factors used for stratification include age, gender, and anxiety level.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/03/2017
Actual
7/03/2017
Date of last participant enrolment
Anticipated
Actual
23/05/2017
Date of last data collection
Anticipated
Actual
25/07/2017
Sample size
Target
130
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 295289 0
University
Name [1] 295289 0
Australian National University
Country [1] 295289 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
Research School of Population Health
Building 62
Mills Road
Acton
ACT
2601
Country
Australia
Secondary sponsor category [1] 294111 0
None
Name [1] 294111 0
Address [1] 294111 0
Country [1] 294111 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296624 0
The Australian National University Human Research Ethics Committee (HREC)
Ethics committee address [1] 296624 0
Ethics committee country [1] 296624 0
Australia
Date submitted for ethics approval [1] 296624 0
23/09/2016
Approval date [1] 296624 0
03/01/2017
Ethics approval number [1] 296624 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71514 0
Mr Brendan Loo Gee
Address 71514 0
Centre for Mental Health Research (CMHR)
Research School of Population Health
ANU College of Medicine, Biology & Environment
63 Eggleston Rd,
The Australian National University
Canberra, ACT, 0200
Country 71514 0
Australia
Phone 71514 0
+61 2 6125 4278
Fax 71514 0
Email 71514 0
[email protected]
Contact person for public queries
Name 71515 0
Brendan Loo Gee
Address 71515 0
Centre for Mental Health Research (CMHR)
Research School of Population Health
ANU College of Medicine, Biology & Environment
63 Eggleston Rd,
The Australian National University
Canberra, ACT, 0200
Country 71515 0
Australia
Phone 71515 0
+61 2 6125 4278
Fax 71515 0
Email 71515 0
[email protected]
Contact person for scientific queries
Name 71516 0
Philip Batterham
Address 71516 0
Centre for Mental Health Research (CMHR)
Research School of Population Health
ANU College of Medicine, Biology & Environment
63 Eggleston Rd,
The Australian National University
Canberra, ACT, 0200
Country 71516 0
Australia
Phone 71516 0
+61 2 6125 1031
Fax 71516 0
Email 71516 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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